Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2

NCT01662986 | Completed Phase 4 Results

• 1 other identifier: 205.478
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 50

Brief Summary

A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.

  Change from baseline of trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study drug. Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.

  Baseline and 12 weeks

• Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).

  Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality. Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed. This endpoint was analysed using combined data, as specified in the analysis plan

  from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years

Secondary Outcomes (12)

• Change From Baseline of Trough FVC at 12 Weeks on Study Drug.

  baseline and 12 weeks

• Percentage of Patients With Adverse Clinical Event During on Study.

  from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years

• Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)

  Baseline and week 12

• Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)

  Baseline and week 12

• Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)

  from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years

Study Arms (2)

18 mcg tiotropium bromide

ACTIVE COMPARATOR

Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler

Drug: tiotropium bromide

placebo

PLACEBO COMPARATOR

Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler

Drug: Placebo

Interventions

tiotropium bromide DRUG

18 mcg once a day (QD)

18 mcg tiotropium bromide

Placebo DRUG

Once a day (QD)

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures
• Male or female subjects 40 years of age or older.
• Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days. Determination of accuracy of admission diagnosis will be at the discretion of the investigator.
• Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).
• Discharged from the hospital =10 days from date of randomization.
• All subjects must have a diagnosis of COPD (P12-01205), and have documented airway obstruction with a post-bronchodilator Force Expiratory Volume in 1 second (FEV1)\\ Force vital capacity (FVC) \<0.7(See Section 5.1.2, Pulmonary Function Testing). The diagnosis of COPD can be made at Visit 1 if no Pulmonary Function Testing (PFT) data available within the past 12 months.
• Subjects must be current or ex-smoker with a smoking history of =10 pack-years:
• Pack-years = Number of cigarettes/day x years of smoking 20 cigarettes/ pack 8. Subjects must be able to inhale medication in a competent manner from the HandiHaler® device (Appendix 10.1) and from a metered dose inhaler (MDI).

You may not qualify if:

• No more than 30 days of therapy with any long-acting inhaled anticholinergic over preceding 3 months prior to discharge from the hospital, and no therapy with any long acting anticholinergic post discharge (no use between hospital discharge and randomization) or any other restricted concomitant medications
• Presence of a significant disease (in the opinion of the investigator) which may put the subject at risk because of participation in the study or may influence the subject's ability to participate in the study for up to 2 years.
• A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
• Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
• Subjects with asthma (subject treated for asthma in the last 2 years, history of childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary thromboembolic disease or known active tuberculosis.
• \. Malignancy for which the subject has undergone resection, radiation, chemotherapy or biological treatments within the last two years or is currently on active radiation therapy, chemotherapy or biological treatment. Subjects with treated basal cell carcinoma and non-invasive squamous cell skin carcinoma are allowed.
• \. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.
• \. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
• \. Known moderate to severe renal impairment as judged by the investigator. 11. Known narrow angle glaucoma as judged by the investigator. 12. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms are controlled on treatment may be included.
• \. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or sub dermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial.
• \. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.
• \. Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.
• \. Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.
• \. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

205.478.00243 Boehringer Ingelheim Investigational Site

Montgomery, Alabama, United States

Location

205.478.00208 Boehringer Ingelheim Investigational Site

Flagstaff, Arizona, United States

Location

205.478.00260 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Location

205.478.00241 Boehringer Ingelheim Investigational Site

Loma Linda, California, United States

Location

205.478.00240 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

205.478.00237 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

205.478.00231 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

205.478.00209 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

205.478.00250 Boehringer Ingelheim Investigational Site

Glastonbury, Connecticut, United States

Location

205.478.00229 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

205.478.00200 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

205.478.00212 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

205.478.00265 Boehringer Ingelheim Investigational Site

Kissimmee, Florida, United States

Location

205.478.00246 Boehringer Ingelheim Investigational Site

Lehigh Acres, Florida, United States

Location

205.478.00248 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

205.478.00215 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

205.478.00261 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

205.478.00233 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

205.478.00236 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Location

205.478.00205 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Location

205.478.00225 Boehringer Ingelheim Investigational Site

Evanston, Illinois, United States

Location

205.478.00264 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

Location

205.478.00254 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Location

205.478.00249 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

Location

205.478.00257 Boehringer Ingelheim Investigational Site

Hazard, Kentucky, United States

Location

205.478.00234 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

205.478.00242 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

205.478.00258 Boehringer Ingelheim Investigational Site

Eunice, Louisiana, United States

Location

205.478.00256 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

205.478.00210 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

205.478.00220 Boehringer Ingelheim Investigational Site

Towson, Maryland, United States

Location

205.478.00204 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

205.478.00247 Boehringer Ingelheim Investigational Site

Winston Salem, Massachusetts, United States

Location

205.478.00263 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

Location

205.478.00201 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Location

205.478.00239 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

205.478.00227 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Location

205.478.00253 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

205.478.00226 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

205.478.00232 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

205.478.00203 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

205.478.00206 Boehringer Ingelheim Investigational Site

Wyomissing, Pennsylvania, United States

Location

205.478.00219 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

205.478.00222 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Location

205.478.00235 Boehringer Ingelheim Investigational Site

Kingwood, Texas, United States

Location

205.478.00217 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Location

205.478.00216 Boehringer Ingelheim Investigational Site

Temple, Texas, United States

Location

205.478.00230 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

Location

205.478.00202 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

205.478.00224 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

The original protocol planned to randomize 604 subjects. However this was not reached due to low patient enrollment.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: July 20, 2015

Record last verified: 2018-09

Locations

US (50)